(86 days)
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No
The device description and intended use clearly state that the device is a simple mechanical peak flow monitor that produces a whistle based on airflow, with no mention of data processing, algorithms, or learning capabilities.
No
Explanation: The device is a peak flow monitor used to monitor respiratory status and indicate when medical treatment is needed, rather than directly treating a condition itself.
Yes
The device is described as allowing users to "monitor their respiratory status" and providing an "indication that medical treatment is necessary or that it is not effective" based on the absence of a whistle, which points to its use in assessing a health condition.
No
The device description explicitly states it is a "peak flow monitor" and describes a physical mechanism ("ability to produce a whistle when blowing into the RESPALERT"), indicating it is a hardware device, not software only.
Based on the provided information, the Harwill Medical RESPALERT is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The RESPALERT measures the rate of air forced out of the lungs, which is a physiological measurement of lung function, not an analysis of a biological sample (like blood, urine, or tissue).
- The device's function is based on a physical measurement (airflow rate) and a simple indicator (whistle), not on the detection or measurement of substances within a biological sample.
The RESPALERT is a medical device used for monitoring a physiological parameter (peak expiratory flow), which falls under the category of in vivo diagnostics or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Product codes
73 BZH
Device Description
The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lungs
Indicated Patient Age Range
adults
Intended User / Care Setting
medical doctor or health care worker / hospital or clinic
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, oriented towards the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Mr. E.J. Smith Harwill Medical (PTY) LTD. c/o Smith Associates P.O. Box 4341 Crofton, MD 21114
Re: K992618 RESPALERT Regulatory Class: II (two) Product Code: 73 BZH Dated: July 29, 1999 Received: August 4, 1999
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. E.J. Smith
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number ¾800). 638-2041 or (301) 443-6597, or at its internet-address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Christy touman for
Ceila M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Whistle Watch RESPALERT
Classification Panel: 73BZH, 868.1860
Indications for Use:
The Harwill Medical RESPALERT is a peak flow monitor that has been-designed to enable adults who suffer from respiratory diseases, such as asthma, chronic bronchitis, emphysema or chronic obstructive lung disease (COPD) to monitor their respiratory status by measuring the rate at which the user can force air out of the lungs. The RESPALERT does not create a reading, but the ability to produce a whistle shows that the lung condition is under control.
The RESPALERT must be set by a medical doctor or health care worker to a pre-determined measurement using a lung function apparatus at a hospital or clinic. If the patient is unable to produce a whistle when blowing into the RESPALERT, it is an indication that medical treatment is necessary or that it is not effective.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Christy Loumen
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ |
|---|---|
| or | |
| Over the Counter Use |
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